83 FR 58598 - Importer of Controlled Substances Application: Janssen Pharmaceuticals Inc.

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 83, Issue 224 (November 20, 2018)

Page Range		58598-58599
FR Document		2018-25226

Federal Register, Volume 83 Issue 224 (Tuesday, November 20, 2018)

[Federal Register Volume 83, Number 224 (Tuesday, November 20, 2018)]
[Notices]
[Pages 58598-58599]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-25226]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Application: Janssen 
Pharmaceuticals Inc.

ACTION: Notice of application.

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DATES: Registered bulk manufacturers of the affected basic classes, and 
applicants therefore, may file written comments on or objections to the 
issuance of the proposed registration on or before December 20, 2018. 
Such persons may also file a written request for a hearing on the 
application on or before December 20, 2018.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/DPW, 
8701 Morrissette Drive, Springfield, Virginia 22152. All requests for 
hearing must be sent to: Drug Enforcement Administration, Attn: 
Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All 
requests for hearing should also be sent to: (1) Drug Enforcement 
Administration, Attn: Hearing Clerk/OALJ, 8701 Morrissette Drive, 
Springfield, Virginia 22152; and (2) Drug Enforcement Administration, 
Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, 
Springfield, Virginia 22152. Comments and requests for hearings on 
applications to import narcotic raw material are not appropriate. 72 FR 
3417 (January 25, 2007)

SUPPLEMENTARY INFORMATION: The Attorney General has delegated his 
authority under the Controlled Substances Act to the Administrator of

[[Page 58599]]

the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority 
to exercise all necessary functions with respect to the promulgation 
and implementation of 21 CFR part 1301, incident to the registration of 
manufacturers, distributors, dispensers, importers, and exporters of 
controlled substances (other than final orders in connection with 
suspension, denial, or revocation of registration) has been redelegated 
to the Assistant Administrator of the DEA Diversion Control Division 
(``Assistant Administrator'') pursuant to section 7 of 28 CFR part 0, 
appendix to subpart R.
    In accordance with 21 CFR 1301.34(a), this is notice that on 
September 13, 2018, Janssen Pharmaceuticals Inc., 1440 Olympic Drive, 
Bldgs. 1-5 & 7-14, Athens, Georgia 30601-1645, applied to be registered 
as an importer of the following basic classes of controlled substances:

------------------------------------------------------------------------
         Controlled  substance           Drug code         Schedule
------------------------------------------------------------------------
Thebaine..............................         9333  II
Poppy Straw Concentrate...............         9670  II
Tapentadol............................         9780  II
------------------------------------------------------------------------

    The company plans to import an intermediate form of tapentadol 
(9780) to bulk manufacture tapentadol for distribution to its 
customers. The company plans to import thebaine (9333) derivatives as 
reference standards. The company plans to import concentrated poppy 
straw (9670) to bulk manufacture other controlled substances. No other 
activity for these drug codes is authorized for this registration.

    Dated: November 6, 2018.
John J. Martin,
Assistant Administrator.
[FR Doc. 2018-25226 Filed 11-19-18; 8:45 am]
 BILLING CODE 4410-09-P

58598 Federal Register / Vol. 83, No. 224 / Tuesday, November 20, 2018 / Notices

no longer authorized by State law to authority to dispense controlled Certificate of Registration No.
engage in the . . . dispensing of substances under the laws of Texas, the FB2033049, issued to Eldor Brish, M.D.,
controlled substances.’’ Also, DEA has State in which he is registered with the be, and it hereby is, revoked. I further
long held that the possession of DEA. Accord Gazelle A. Craig, D.O., 83 order that any pending application of
authority to dispense controlled FR 27628, 27631 (2018). Eldor Brish to renew or modify the
substances under the laws of the State Moreover, because ‘‘the controlling above registration, or any pending
in which a practitioner engages in question’’ in a proceeding brought application of Eldor Brish for any other
professional practice is a fundamental under 21 U.S.C. 824(a)(3) is whether the DEA registration in the State of Texas,
condition for obtaining and maintaining holder of a DEA registration ‘‘is be, and it hereby is, denied. This Order
a practitioner’s registration. See, e.g., currently authorized to handle is effective immediately.5
James L. Hooper, 76 FR 71371 (2011), controlled substances in the [S]tate,’’ Dated: October 31, 2018.
pet. for rev. denied, 481 Fed. Appx. 826 Hooper, 76 FR at 71371 (quoting Anne
Uttam Dhillon,
(4th Cir. 2012); see also Frederick Marsh Lazar Thorn, 62 FR 12847, 12848
Acting Administrator.
Blanton, 43 FR 27616 (1978) (‘‘State (1997)), the Agency has also long held
that revocation is warranted even where [FR Doc. 2018–25223 Filed 11–19–18; 8:45 am]
authorization to dispense or otherwise
a practitioner has lost his state authority BILLING CODE 4410–09–P
handle controlled substances is a
prerequisite to the issuance and by virtue of the State’s use of summary
maintenance of a Federal controlled process and the State has yet to provide
a hearing to challenge the suspension. DEPARTMENT OF JUSTICE
substances registration.’’).
This rule derives from the text of two Bourne Pharmacy, 72 FR 18273, 18274 Drug Enforcement Administration
provisions of the CSA. First, Congress (2007); Wingfield Drugs, 52 FR 27070,
defined ‘‘the term ‘practitioner’ [to] 27071 (1987). Thus, it is of no [Docket No. DEA–392]
mean[ ] a . . . physician . . . or other consequence that the TMB has
person licensed, registered or otherwise suspended Respondent’s medical Importer of Controlled Substances
permitted, by . . . the jurisdiction in license and that Respondent may Application: Janssen Pharmaceuticals
which he practices . . . to distribute, prevail in a future state hearing.4 What Inc.
dispense, [or] administer . . . a is consequential is the fact that ACTION: Notice of application.
controlled substance in the course of Respondent is not currently authorized
professional practice.’’ 21 U.S.C. to dispense controlled substances in DATES: Registered bulk manufacturers of
802(21). Second, in setting the Texas, the State in which he is the affected basic classes, and
requirements for obtaining a registered. See GX3 to Govt. Mot., at 5. applicants therefore, may file written
practitioner’s registration, Congress Here, there is no dispute over the comments on or objections to the
directed that ‘‘[t]he Attorney General material fact that Respondent is no issuance of the proposed registration on
shall register practitioners . . . if the longer currently authorized to dispense or before December 20, 2018. Such
applicant is authorized to dispense . . . controlled substances in Texas, the State persons may also file a written request
controlled substances under the laws of in which he is registered. Accordingly, for a hearing on the application on or
the State in which he practices.’’ 21 Respondent is not entitled to maintain before December 20, 2018.
U.S.C. 823(f). his DEA registration. I will therefore ADDRESSES: Written comments should
As already noted, the TMB adopt the ALJ’s recommendation that I
be sent to: Drug Enforcement
temporarily suspended Respondent’s revoke Respondent’s registration. R.D.,
Administration, Attention: DEA Federal
Texas license to practice medicine. at 7. I will also deny any pending
Register Representative/DPW, 8701
Under the Texas Controlled Substances application to renew or to modify his
Morrissette Drive, Springfield, Virginia
Act, a ‘‘practitioner’’ includes a registration, or any pending application
22152. All requests for hearing must be
‘‘physician’’ who is licensed ‘‘to for any other DEA registration in Texas,
sent to: Drug Enforcement
dispense . . . or administer a controlled as requested in the Show Cause Order.
Administration, Attn: Administrator,
substance in the course of professional Order to Show Cause, at 1.
8701 Morrissette Drive, Springfield,
practice.’’ Tex. Controlled Substances
Order Virginia 22152. All requests for hearing
Act § 481.002(39)(A). Under the Texas
Pursuant to the authority vested in me should also be sent to: (1) Drug
Medical Practice Act, a ‘‘physician’’ is
‘‘a person licensed to practice by 21 U.S.C. 823(f) and 824(a), as well Enforcement Administration, Attn:
medicine,’’ Tex. Occ. Code as 28 CFR 0.100(b), I order that DEA Hearing Clerk/OALJ, 8701 Morrissette
§ 151.002(a)(12), and ‘‘practicing Drive, Springfield, Virginia 22152; and
medicine’’ means the ‘‘diagnosis, 4 Similarly, and contrary to Respondent’s claim, (2) Drug Enforcement Administration,
treatment, or offer to treat a . . . disease Due Process does not require the ALJ to delay Attn: DEA Federal Register
. . . by any system or method.’’ Id.
summary disposition of the case until after Representative/DPW, 8701 Morrissette
completion of his Texas State Informal Show Drive, Springfield, Virginia 22152.
§ 151.002(a)(13). Moreover, a ‘‘person Compliance and Settlement Conference. Resp. Br. at
may not practice medicine in th[e] state 3–4. Rather, Due Process required the ALJ to Comments and requests for hearings on
unless the person holds a license issued provide Respondent the opportunity to respond to applications to import narcotic raw
under’’ the Medical Practice Act, id.
the Order to Show Cause and the Government’s material are not appropriate. 72 FR 3417
Request for Summary Disposition. The ALJ did (January 25, 2007)
§ 155.001, and ‘‘[a] person commits an provide Respondent such an opportunity, and the
offense if the person practices medicine Respondent did so respond. Respondent provided SUPPLEMENTARY INFORMATION: The
in this state in violation of’’ the Act. Id. no authority for the notion that the ALJ violated Attorney General has delegated his
Respondent’s right to Due Process by, in fact, authority under the Controlled
§ 165.152(a). As the ALJ correctly noted, providing Respondent an opportunity to be heard
the TMB found in both of its Temporary instead of delaying such opportunity. Respondent’s Substances Act to the Administrator of
Suspension Orders that Respondent had claim that the ALJ should have delayed his
violated several provisions of Section recommended decision is particularly unavailing 5 For the same reasons which led the TMB to

where, as here, there are no controlling facts in suspend Respondent’s Texas medical license, I
164 of the Texas Occupational Code. dispute. Accord Emmanuel O. Nwaokocha, M.D., 82 conclude that the public interest necessitates that
See R.D., at 5. Thus, I find that FR 26516, 26518 n.3 (2017); see also Kenneth N. this Order be effective immediately. 21 CFR
Respondent is currently without Woliner, M.D., 83 FR 7223, 7225 n.6 (2018). 1316.67.

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Federal Register / Vol. 83, No. 224 / Tuesday, November 20, 2018 / Notices 58599

the Drug Enforcement Administration grounds that Applicant ‘‘ha[s] been result, the DI stated in her Declaration
(DEA), 28 CFR 0.100(b). Authority to convicted of a felony relating to that she mailed a copy of the Show
exercise all necessary functions with controlled substances’’ and because Cause Order by certified mail and
respect to the promulgation and granting Respondent a ‘‘registration addressed it to Applicant at the
implementation of 21 CFR part 1301, would be inconsistent with the public Victorville United States Penitentiary in
incident to the registration of interest.’’ Appendix (App.) 1 to Adelanto, California. Id. 2 In her
manufacturers, distributors, dispensers, Government’s Request for Final Agency Declaration, the DI attached and
importers, and exporters of controlled Action (RFAA), at 1 (citing 21 U.S.C. authenticated a return receipt from the
substances (other than final orders in 823(f), 824(a)(2), (a)(4)). U.S. Postal Service confirming that the
connection with suspension, denial, or With respect to the Agency’s mailing was so addressed and was
revocation of registration) has been jurisdiction, the Show Cause Order delivered to that penitentiary on June
redelegated to the Assistant alleged that on May 4, 2015, Applicant 15, 2018. Id.; see Attachment A to App.
Administrator of the DEA Diversion submitted an application for a DEA 4. I therefore find that the Government
Control Division (‘‘Assistant registration ‘‘to handle controlled
accomplished service on June 15, 2018.
Administrator’’) pursuant to section 7 of substances in Schedules II–IV, with
See Warren B. Dailey, M.D., 82 FR
28 CFR part 0, appendix to subpart R. Application Number W15031876C, at
46525, 46526 (2017) (holding that
In accordance with 21 CFR 4130 Eadhill Place, Whittier, CA.’’ Id. at
2.1 sending Show Cause Order to
1301.34(a), this is notice that on Respondent by certified mail at U.S.
September 13, 2018, Janssen As to the substantive grounds for the
proceeding, the Show Cause Order penitentiary and with proof of return
Pharmaceuticals Inc., 1440 Olympic receipt was sufficient to establish that
Drive, Bldgs. 1–5 & 7–14, Athens, alleged that ‘‘[o]n or about December 4,
2017, a jury convicted’’ Applicant of 26 Government lawfully accomplished
Georgia 30601–1645, applied to be service).
registered as an importer of the counts of unlawful distribution of
following basic classes of controlled controlled substances (specifically, On October 3, 2018, the Government
substances: hydrocodone, alprazolam, and forwarded its Request for Final Agency
carisoprodol) in violation of 21 U.S.C. Action and evidentiary record to my
Controlled Drug code Schedule
841(a)(1) and 18 U.S.C. 2 and that the Office. In its Request, the Government
substance ‘‘[j]udgment was entered on April 23, represents that more than 30 days had
Thebaine .......................... 9333 II 2018.’’ Id. The Order asserted that passed since Applicant had been served
Poppy Straw Concentrate 9670 II Respondent’s ‘‘[c]onviction of a felony and that ‘‘DEA had not received a
Tapentadol ....................... 9780 II relating to controlled substances request for hearing or any other reply’’
warrants denial of [his] application for from him during that time. RFAA, at 3.
The company plans to import an registration.’’ Id. (citing 21 U.S.C. Based on the Government’s
intermediate form of tapentadol (9780) 824(a)(2)). The Order also asserted that representation and the record, I find that
to bulk manufacture tapentadol for granting Respondent’s application more than 30 days have passed since the
distribution to its customers. The would be ‘‘inconsistent with the public
company plans to import thebaine Order to Show Cause was served on the
interest’’ in light of his felony
(9333) derivatives as reference Applicant, and he has neither requested
convictions. Id. (citing 21 U.S.C. 823(f),
standards. The company plans to import a hearing nor submitted a written
824(a)(4)).
concentrated poppy straw (9670) to bulk The Show Cause Order notified statement in lieu of a hearing. See 21
manufacture other controlled Applicant of (1) his right to request a CFR 1301.43(d). Accordingly, I find that
substances. No other activity for these hearing on the allegations or to submit Applicant has waived his right to a
drug codes is authorized for this a written statement in lieu of a hearing, hearing or to submit a written statement
registration. (2) the procedure for electing either and issue this Decision and Order based
option, and (3) the consequence for on relevant evidence submitted by the
Dated: November 6, 2018. Government. See id. I make the
failing to elect either option. Id. at 2–3.
John J. Martin, following findings.
(citing 21 CFR 1301.43). The Order also
Assistant Administrator.
notified Applicant of his right to submit
[FR Doc. 2018–25226 Filed 11–19–18; 8:45 am] a corrective action plan. Id. at 3–4 2 The DI also stated in her Declaration that the

BILLING CODE 4410–09–P (citing 21 U.S.C. 824(c)(2)(C)). Show Cause Order ‘‘was emailed to [Applicant’s]
criminal defense attorney’’ by a Task Force Officer
With respect to service, a Diversion ‘‘on or about June 11, 2018.’’ Id. However, this
Investigator (DI) with DEA’s Los attempt at service of the Order pursuant to 21
DEPARTMENT OF JUSTICE Angeles Field Division executed a U.S.C. 824(c), standing alone, would be insufficient
Declaration on September 19, 2018 for at least two reasons. First, the Government failed
Drug Enforcement Administration to establish that the attorney had ‘‘the power to
stating that she ‘‘learned that following accept service’’ on behalf of the Applicant in this
Edward A. Ridgill, M.D.; Decision and his conviction, [Applicant] was proceeding. Warren B. Dailey, M.D., 82 FR 46525,
Order incarcerated at Victorville Federal 46526 (2017) (internal citations and quotations
Prison . . . in Adelanto, CA.’’ App. 4 omitted). Second, assuming the attorney had such
authority, the record does not contain (1) a
On May 15, 2018, the Assistant (Declaration of DI) to RFAA, at 2. As a statement that explains whether the DI had
Administrator, Diversion Control independent personal knowledge of the email, (2)
Division, Drug Enforcement 1 The Show Cause Order also alleged that a declaration from the Task Force Officer or another
Administration (DEA), issued an Order Applicant was previously ‘‘registered with the DEA declarant who has personal knowledge of the email,
as a practitioner authorized to handle controlled or (3) any other evidence corroborating the DI’s
to Show Cause to Edward A. Ridgill, substances in Schedules II–V’’ under DEA statement that the Task Force Officer had emailed
M.D., (Applicant), of Whittier, Certificate of Registration No. FR3094997 at 3625 E. the attorney. Cf. Richard Hauser, M.D., 83 FR
California. The Show Cause Order Martin Luther King Boulevard, Suite 9, Lynwood, 26308, 26309 n.5 (2018) (finding that a DI’s
proposed the denial of Applicant’s California. Id. at 1. The Order alleged that declaration that he ‘‘verified’’ a document’s
Applicant ‘‘voluntarily surrendered’’ this authenticity by conferring with another DI was
application for a DEA Certificate of registration on March 12, 2015 ‘‘during [his] arrest insufficient absent a declaration from a DI with
Registration, ‘‘Application Number for conspiracy to distribute controlled substances.’’ personal knowledge of the document’s authenticity
W15031876C,’’ as a practitioner on the Id. or other evidence to corroborate its authenticity).

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Document Created: 2018-11-20 07:59:19
Document Modified: 2018-11-20 07:59:19

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice of application.
Dates		Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before December 20, 2018. Such persons may also file a written request for a hearing on the application on or before December 20, 2018.
FR Citation		83 FR 58598

83 FR 58598 - Importer of Controlled Substances Application: Janssen Pharmaceuticals Inc.

DEPARTMENT OF JUSTICEDrug Enforcement Administration

Federal Register Volume 83, Issue 224 (November 20, 2018)

DEPARTMENT OF JUSTICE
Drug Enforcement Administration